INTRODUCTION

Strip-Immunoassay for the detection of IgG and IgM antibodies against Toxoplasma gondii, rubella virus, cytomegalovirus (CMV), and herpes simplex virus type 1 and 2 (HSV-1/2)

recomLine TORCH Screening IgG
The antigens enable differentiated diagnosis in the first step analysis (screening). Interpretation of the recomLine TORCH Screening IgG test follows a two-band strategy. The major band (lysate antigen) shows the presence or the absence of specific antibodies to an infectious agent and the ancillary band (e.g. recombinant antigen) is specific for each pathogen and allows further determination (see Table below).

recomLine TORCH Screening IgM
The diagnostic information presented by the recomLine TORCH Screening IgG assay is supported by the recomLine TORCH Screening IgM assay. The test strips contain one band per infectious agent (four pathogen-specific lysate antigen bands per test strip), which enables the identification of specific IgM class antibodies to T. gondii, rubella virus, CMV, and HSV type 1 and 2, respectively. Sensitivity of the T. gondii-specific cell lysate antigen band is enhanced by an early phase antigen ROP1c.

PRODUCT ADVANTAGES

• The recomLine TORCH Screening IgG and IgM is unique on the market allowing screening of 4 pathogens on one stripe as well as determination of the time of infection (CMV, T. gondii), protective or non-protective immune status (Rubella) and type differentiation (HSV-2)
• Fast and easy test procedure
• Well defined interpretation of bands and pattern due to easy to read bands
• No automation necessary and especially suitable for small laboratories with low sample throughput
• Easy test procedure; automation possible
• Easy and objective evaluation and documentation by recomScan software
• Safe evaluation due to strip specific controls (cut-off and conjugate control)
• Separate detection of IgG and IgM antibodies possible
• Test procedure and reagents identical in all MIKROGEN strip tests - reagents exchangeable
• CE label: The recomLine TORCH Screening tests meet the high standard of the EC directive 98/79/EC on in vitro diagnostic medical devices

TESTPRINCIPLE AND PROCEDURE

1^st Incubation
A test strip loaded with TORCH antigens is incubated with diluted serum or plasma in a dish for 1 hour.

wash 3 times

2^nd Incubation
Peroxidase conjugated anti-human antibodies (IgG or IgM specific) are added. Incubate for 45 minutes.

wash 3 times

Color reaction
8 minutes after addition of the coloring solution, insoluble colored bands develop at the sites on the test strips occupied by antibodies.

PATHOGEN SPECIFIC ANTIGENS USED IN RECOMLINE TORCH SCREENING IGG

SAMPLE STRIPS

STORAGE AND SHELF LIVE

At 4 °C 12 months from the date of production

COMMERCIAL PRODUCT